MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA 4; VENTILATORS, INTENSIVE CARE

Catalog Number 8411740

Device Problems Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation was performed on the basis of the information available, including the logbook.The evaluation of the logbook confirmed the reported event.The external and internal batteries of the dc option were identified as the root cause of the error.The evita 4 was operated on battery at 08:21 a.M.On the (b)(6) 2020, but the state of charge of both the internal and external batteries was not sufficient to maintain appropriate ventilation during battery operation.The ventilator attempted to maintain power by switching back and forth between the internal and external batteries and alerted visually and acoustically.The logbook shows that these alarms have been silenced.At 08:40 a.M.The power supply collapsed and the evita 4 performed warm starts.If the power supply collapses, ventilation is stopped, the screen turns black and the emergency breathing system opens automatically so that the patient can breathe spontaneously.As soon as the power supply is back on, a warm start (duration approx.8 seconds) takes place and the ventilation is continued with the previous parameters.Immediately after restarting the ventilation, an "mv low" alarm is generated, which continues until the applied volume is greater than the lower set limit value for the minute volume.In this case, the evita 4 alarms acoustically with a power failure alarm via the power failure horn for at least 2 minutes.In the reported event, the warm starts were also accompanied by a power failure alarm in accordance with the specifications and as reported.At 08:54 a.M.The last battery-related alarm in the period under consideration was recorded in the logbook; after that the unit was operated for about 2 hours until it was switched to standby at 10:42 a.M.The device has alerted about problems with the battery operated power supply.The internal and external batteries are wearing parts and are replaced every 2 years during maintenance by the service department.However, the lifetime of the batteries depends on the specific use.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported, that the device evita 4 has constantly switched between internal and external battery with alarm during battery operation and has later switched off with a continuous beep.There were no patient consequences reported.

• Brand Name: EVITA 4
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10037744
• MDR Text Key: 190288040
• Report Number: 9611500-2020-00149
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K980642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8411740
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1